(367 days)
The MP RapidOXY Test Strip is an immunochromatographic one-step in-vitro test designed for qualitative determination of oxycodone in human urine specimens above a cut-off level of 100 ng/ml. The MP RapidOXY Test Strip may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
The MP RapidBUP Test Strip is an immunochromatography based one step in vitro test. It is designed for qualitative determination of the major metabolite of buprenorphine, buprenorphine-3-beta-d-glucuronide, in human urine specimens at cut-off level of 10 ng/ml. The MP RapidBUP Test Strip may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
The MP RapidOXY Test Strip and the MP RapidBUP Test Strip are based on the principle of specific immunochemical reaction between antibody and antigen to analyze particular compounds in human urine specimens. The assays rely on the competition for binding antibody between drug conjugate and free drug which may be present in urine. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibodydve conjugate. When the amount of drug is equal or more than the cut-off (i.e., 100 ng/ml oxycodone or 10 ng/ml buprenorphine-3-beta-d-glucuronide, or B-3-beta-d-G), it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line is present in the test window to work as procedural control in both assays. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
The provided text describes two drug-of-abuse test kits: the MP RapidOXY Test Strip (for oxycodone) and the MP RapidBUP Test Strip (for buprenorphine). However, the document does not contain explicit "acceptance criteria" in the typical sense of performance metrics (e.g., sensitivity, specificity thresholds) that a study aims to meet. Instead, the document outlines the "intended use" and "cut-off levels" which serve as the functional definitions for the device's performance. The "study" referenced within the document is implicitly the submission of "Performance Data and the Accuracy Data" to the FDA, but the details of these studies (e.g., specific methodologies, results, sample sizes, ground truth establishment) are not provided in the given text.
Therefore, I will populate the table and answer the questions based on the information available in the provided text, and explicitly state when information is not present.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implicit from Intended Use) | Reported Device Performance (as per Intended Use) | Study Proving Performance (Implicit in Submission) |
|---|---|---|
| MP RapidOXY Test Strip | ||
| Qualitative determination of oxycodone in human urine | Qualitative determination of oxycodone in human urine | Performance and Accuracy Data (details not provided) |
| Above a cut-off level of 100 ng/ml | Designed for detection above 100 ng/ml | Performance and Accuracy Data (details not provided) |
| For point-of-care (POC) use | Intended for point-of-care (POC) use | Performance and Accuracy Data (details not provided) |
| Provide preliminary analytical test result | Provides preliminary analytical test result | Performance and Accuracy Data (details not provided) |
| Follow-up with GC/MS for confirmation | Recommended follow-up with GC/MS for confirmatory result | Performance and Accuracy Data (details not provided) |
| MP RapidBUP Test Strip | ||
| Qualitative determination of buprenorphine's metabolite (buprenorphine-3-β-d-glucuronide) in human urine | Qualitative determination of buprenorphine's metabolite (buprenorphine-3-β-d-glucuronide) in human urine | Performance and Accuracy Data (details not provided) |
| Above a cut-off level of 10 ng/ml | Designed for detection above 10 ng/ml | Performance and Accuracy Data (details not provided) |
| For point-of-care (POC) use | Intended for point-of-care (POC) use | Performance and Accuracy Data (details not provided) |
| Provide preliminary analytical test result | Provides preliminary analytical test result | Performance and Accuracy Data (details not provided) |
| Follow-up with GC/MS for confirmation | Recommended follow-up with GC/MS for confirmatory result | Performance and Accuracy Data (details not provided) |
Detailed Study Information (Based on Provided Text):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document mentions "Performance Data and the Accuracy Data" but does not detail the sample sizes for these studies.
- Data Provenance: Not specified in the provided text.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified in the provided text.
- Qualifications of Experts: Not specified in the provided text.
- The document states that Gas Chromatography/Mass Spectrometry (GC/MS) "has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA)" and is recommended for follow-up. This implies GC/MS results would likely be the basis for ground truth, which is an analytical method rather than expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the provided text.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not specified. This is a point-of-care immunoassay "Test Strip" for qualitative determination, not a system involving "human readers" or "AI assistance" in the typical sense of diagnostic imaging or complex analytical interpretation. The device provides a visual, qualitative result.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The devices (test strips) are designed to provide a "preliminary analytical test result" qualitatively and visually. This implies a standalone performance without human interpretation or adjustment being part of the primary result generation, although a human reads the visual result. The device itself is an "algorithm" in the sense of a chemical reaction with a defined output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document explicitly states that Gas Chromatography/Mass Spectrometry (GC/MS) is the "preferred confirmatory method." This indicates that analytical confirmation (GC/MS) would be the ground truth for the studies supporting the device's accuracy.
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The sample size for the training set
- Not specified in the provided text. As these are immunoassays (chemical tests), the concept of a "training set" in the context of machine learning or AI is not directly applicable in the same way. Performance data would typically involve testing against known positive and negative samples, and samples spiked with controlled concentrations of the target analyte.
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How the ground truth for the training set was established
- Not specified in the provided text. Assuming "training set" refers to samples used to optimize the test's performance characteristics (e.g., cut-off, cross-reactivity), the ground truth for such samples would likely also be established through analytical methods like GC/MS or by preparing samples with known concentrations of the drug/metabolite.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).